ColpotomizOR Tube C45-TV

GUDID 09349967001479

45mm diameter trans-vaginal tube, 3 way valve, Silicone tie

THE O R COMPANY PTY LTD

Colpotomy tube
Primary Device ID09349967001479
NIH Device Record Key6602f7fb-085b-4902-9d16-64b67664f5e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameColpotomizOR Tube
Version Model Number45mm
Catalog NumberC45-TV
Company DUNS744346235
Company NameTHE O R COMPANY PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter
Outer Diameter45 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS109349967001455 [Primary]
GS109349967001462 [Package]
Contains: 09349967001455
Package: Outer Box [5 Units]
In Commercial Distribution
GS109349967001479 [Package]
Contains: 09349967001462
Package: Shipper box [3 Units]
In Commercial Distribution

FDA Product Code

HEWCuldoscope (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-04-04
Device Publish Date2017-11-16

On-Brand Devices [ColpotomizOR Tube]

09349967002629C45-TV
09349967002599C35-TV
0934996700147945mm diameter trans-vaginal tube, 3 way valve, Silicone tie
0934996700144835mm Diameter Trans-Vaginal Tube, 3 Way Valve and Silicone Tie

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